How the case against the

MMR vaccine was fixed

BMJ, the British Medical Journal, 5 January 2011

Brian Deer

In the first part of a special BMJ series, Brian Deer exposes the bogus data behind claims that launched a worldwide scare over the measles, mumps, and rubella vaccine, and reveals how the appearance of a link with autism was manufactured at a London medical school

When I broke the news to the father of child 11, at first he did not believe me. “Wakefield told us my son was the 13th child they saw,” he said, gazing for the first time at the now infamous research paper which linked a purported new syndrome with the measles, mumps, and rubella (MMR) vaccine. “There’s only 12 in this.”

That paper was published in the Lancet on 28 February 1998. It was retracted on 2 February 2010. Authored by Andrew Wakefield, John Walker-Smith, and 11 others from the Royal Free medical school, London, it reported on 12 developmentally challenged children, and triggered a decade long public health scare.

“Onset of behavioural symptoms was associated by the parents with measles, mumps, and rubella vaccination in eight of the 12 children,” began the paper’s “findings.” Adopting these claims as fact, its “results” section added: “In these eight children the average interval from exposure to first behavioural symptoms was 6.3 days (range 1-14).”

Mr 11, an American engineer, looked again at the paper: a five page case series of 11 boys and one girl, aged between 3 and 9 years. Nine children, it said, had diagnoses of “regressive” autism, and all but one were reported with “non-specific colitis.” The “new syndrome” brought these together, linking brain and bowel diseases. His son was the penultimate case.

Running his finger across the paper’s tables, over coffee in London, Mr 11 seemed reassured by his anonymised son’s age and other details. But then he pointed at table 2—headed “neuropsychiatric diagnosis”—and for a second time objected.

“That’s not true.”

Child 11 was among the eight whose parents apparently blamed MMR. The interval between his vaccination and the first “behavioural symptom” was reported as 1 week. This symptom was said to have appeared at age 15 months. But his father, whom I had tracked down, said this was wrong.

“From the information you provided me on our son, who I was shocked to hear had been included in their published study,” he wrote to me, after we met again in California, “the data clearly appeared to be distorted.”

He backed his concerns with medical records, including a Royal Free discharge summary. Although the family lived 5000 miles from the hospital, in February 1997 the boy (then aged 5) had been flown to London and admitted for Wakefield’s project, the undisclosed goal of which was to help sue the vaccine’s manufacturers.

Wakefield’s “syndrome”

Unknown to Mr 11, Wakefield was working on a lawsuit, for which he sought a bowel-brain “syndrome” as its centrepiece. Claiming an undisclosed £150 (€180, $230) an hour through a Norfolk solicitor named Richard Barr, he had been confidentially put on the payroll two years before the paper was published, eventually grossing him £435,643, plus expenses. Curiously, however, Wakefield had already identified such a syndrome before the project which would reputedly discover it.

“Children with enteritis/disintegrative disorder [an expression he used for bowel inflammation and regressive autism] form part of a new syndrome,” he and Barr explained in a confidential grant application to the UK government’s Legal Aid Board before any of the children were investigated. “Nonetheless the evidence is undeniably in favour of a specific vaccine induced pathology.”

The two men also aimed to show a sudden-onset “temporal association”—strong evidence in product liability. “Dr Wakefield feels that if we can show a clear time link between the vaccination and onset of symptoms,” Barr told the legal board, “we should be able to dispose of the suggestion that it’s simply a chance encounter.”

But child 11’s case must have proved a disappointment. Records show his behavioural symptoms started too soon. “His developmental milestones were normal until 13 months of age,” notes the discharge summary. “In the period 13-18 months he developed slow speech patterns and repetitive hand movements. Over this period his parents remarked on his slow gradual deterioration.”

That put the first symptom two months earlier than reported in the Lancet, and a month before the boy received the MMR vaccination. And this was not the only anomaly to catch the father’s eye. What the paper reported as a “behavioural symptom” was noted in the records as a chest infection.

“Please let me know if Andrew W has his doctor’s license revoked,” wrote Mr 11, who is convinced that many vaccines and environmental pollutants may be responsible for childhood brain disorders. “His misrepresentation of my son in his research paper is inexcusable. His motives for this I may never know.”

The father need not have worried. My investigation of the MMR issue exposed the frauds behind Wakefield’s research. Triggering the longest ever UK General Medical Council fitness to practise hearing, and forcing the Lancet to retract the paper, last May it led to Wakefield and Walker-Smith being struck off the medical register.

Wakefield, now 54, who called no witnesses, was branded “dishonest,” “unethical,” and “callous.” Walker-Smith, now 74, the senior clinician in the project, was found to have presided over “high risk” research without clinical indication or ethical approval. The developmentally challenged children of often vulnerable parents were discovered to have been treated like the doctors’ guinea pigs.

Lawsuit test case

But Mr 11 was not the first parent with a child in the study whom I interviewed during my inquiries. That was Mrs 2: the first of the parents to approach Wakefield. She was sent to him by an anti-vaccine campaign called JABS. Her son had regressive autism, longstanding problems with diarrhoea, and was the prime example of the purported bowel and brain syndrome—still unsubstantiated 14 years later. This boy would appear in countless media reports, and was one of the four “best” cases in Barr’s lawsuit.

I travelled to the family home, 80 miles northeast of London, to hear about child 2 from his mother. That was in September 2003, when the lawsuit fell apart after counsel representing 1500 families said that, on the evidence, Barr’s autism claims would fail. By that time, Mrs 2 had seen her son’s medical records and expert reports written for her case at trial.

Her concerns about MMR had been noted by her general practitioner when her son was 6 years old. But she told me the boy’s troubles began after his vaccination, which he received at 15 months. “He’d scream all night, and he started head banging, which he’d never done before,” she explained.

“When did that begin, do you think?” I asked.

“That began after a couple of months, a few months afterward, but it was still, it was concerning me enough, I remember going back . . .”

“Sorry. I don’t want to be, like, massively pernickety, but was it a few months, or a couple of months?”

“It was more like a few months because he’d had this, kind of, you know, slide down. He wasn’t right. He wasn’t right. Before he started.”

“Not quicker than two months, but not longer than how many months? What are we talking about here?”

“From memory, about six months, I think.”

The next day, she complained to my editors. She said my methods “seemed more akin to the gutter press.” But I was perplexed by her story, since there was no case in the Lancet that matched her careful account.

According to the paper, child 2 had his “first behavioural symptom” two weeks, not six months, after MMR. This was derived from a Royal Free history (citing “headbanging” and “screaming” as the start) taken by Mark Berelowitz, a child psychiatrist and a coauthor of the paper. He saw Mrs 2 during the boy’s admission, at age 8, after she had discussed her son’s story with Wakefield.

As I later discovered, each family in the project was involved in such discussions before they saw the hospital’s clinicians. Wakefield phoned them at home, and must have at least suggestively questioned them, potentially impacting on later history taking. But I knew little of such things then, and shared my confusion with Walker-Smith, whom I met shortly after Mrs 2.

“There is no case in the paper that is consistent with the case history [Mrs 2] has given me,” I told him. “There just isn’t one.”

“Well that could be true,” the former professor of paediatric gastroenterology replied, disarmingly. He knew the case well, having admitted the boy for the project and written reports for Barr, who paid him £23,000.

“Well, so either what she is telling me is not accurate, or the paper’s not accurate.”

“Well I can’t really comment,” he said. “You really touch on an area which I don’t think should be debated like this. And I think these parents are wrong to discuss such details, where you could be put in a position of having a lot of medical details and then try to match it with this, because it is a confidential matter.”

It was not merely medically confidential, it was also legally protected: a double screen against public scrutiny. But responding to my first MMR reports, in the Sunday Times in February 2004, the GMC decided to investigate the cases and requisitioned the children’s records.

The regulator’s main focus was whether the research was ethical. Mine was whether it was true. So as a five member disciplinary panel trawled through the records, with five Queen’s counsel and three defendant doctors, I compared them with what was published in the journal.

Multiple discrepancies

The paper gave the impression that the authors had been scrupulous in documenting the patients’ cases. “Children underwent gastroenterological, neurological, and developmental assessment and review of developmental records,” it explained, specifying that Diagnostic and Statistical Manual of Mental Disorders IV criteria were used for neuropsychiatric diagnoses. “Developmental histories included a review of prospective developmental records from parents, health visitors, and general practitioners.”

But, when the details were dissected before the GMC panel, multiple discrepancies emerged. A syndrome necessarily requires at least some consistency, but, as the records were laid out, Wakefield’s crumbled.

Copyright, Brian Deer. All rights reserved. No portion of this article on MMR and Andrew Wakefield may be copied, retransmitted, reposted, duplicated or otherwise used without the express written approval of the author. Responses, information and other feedback are appreciated - via the briandeer.com contact page